Identification of Barriers and Facilitators of Implementation of the Out-of-Hospital Administration of the Long- Acting Combination Cabotegravir+Rilpivirina.

NCT06643897 | Completed

• 1 other identifier: Substudy LA CAB+RPV
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 9

Brief Summary

The study will identify the barriers and facilitators of implementation of the out-of-hospital administration of CAB+RPV LA from the point of view of staff participating in the study.

Conditions

HIV-1-infection

Keywords

barriers and facilitators; interview; long acting; out-of-hospital by implementation; cabotegravir + rilpivirine (CAB+RPV); HIV-1

Outcome Measures

Primary Outcomes (1)

• Identify the barriers and facilitators of implementation of the out-of-hospital administration of CAB+RPV LA from the point of view of staff participating in the study.

  1\. To assess barriers and facilitators of implementation of the out-of-hospital administration of CAB+RPV LA from the point of view of staff participating in the HOLA study, at any time after the first 6 months of participation in the study. These will be assessed through a 40-50 minute-qualitative interview created for the study, which references the following domains: adaptability to the intervention, consideration of the needs of patients, changes in infrastructure, implementation climate (need of change, compatibility), preparation for implementation (leadership engagement and resource availability), individual characteristics, need for external agents, main stakeholders, execution and final considerations.

  after the first 6 months of participation in the study

Study Arms (1)

Qualitative Interview

OTHER

All study staff who participate in the substudy will be interviewed through a 40-50 minute-qualitative interview.

Other: Qualitative Interview

Interventions

Qualitative Interview OTHER

40-50 minute-qualitative interview.

Qualitative Interview

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participation throughout the HOLA study until the moment of conducting the interviews and direct involvement in the study procedures in a significant way.
• Homogeneous sample between the different roles participating in the study.
• Participants who agree to participate in the substudy and sign the informed consent.

Sponsors & Collaborators

• Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia: lead

Study Sites (9)

Germans Trias I Pujol Hospital

Badalona, Barcelona, 08916, Spain

Location

CAP Dr Robert

Barcelona, 08001, Spain

Location

Centre de Salut Internacional i Malalties Transmissibles Drassanes - Vall d'Hebron

Barcelona, 08001, Spain

Location

BCN CheckPoint

Barcelona, 08015, Spain

Location

Hospital Vall D' Hebrón

Barcelona, 08035, Spain

Location

Cs Leganitos

Málaga, 29601, Spain

Location

Hospital Costa Del Sol

Málaga, 29603, Spain

Location

Cs San Luis de Sabinillas

Málaga, 29692, Spain

Location

Cs San Pedro de Alcántara

Málaga, 29692, Spain

Location

Related Publications (1)

• Hernandez-Sanchez D, Leyva-Moral JM, Olalla J, Negredo E, On Behalf Of The Hola Study Group. Barriers and Facilitators of Implementation of the Non-Hospital-Based Administration of Long-Acting Cabotegravir Plus Rilpivirine in People with HIV: Qualitative Data from the HOLA Study. Viruses. 2025 Jul 16;17(7):993. doi: 10.3390/v17070993.

  PMID: 40733609 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The substudy is a transversal, one arm, multicentric study including the staff participating in the HOLA study, to identify the barriers and facilitators of implementation of the out-of-hospital administration of CAB+RPV LA following a qualitative descriptive design. All study staff who participate in the substudy will be interviewed through a 40-50 minute-qualitative interview

Study Record Dates

• First Submitted: October 8, 2024
• First Posted: October 16, 2024
• Study Start: July 16, 2024
• Primary Completion: October 23, 2024
• Study Completion: October 23, 2024
• Last Updated: January 30, 2025

Record last verified: 2025-01

Locations

ES (9)